Exercise Prescription Guided by Heart Rate Variability in Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-13

Study Completion Date

2022-09-20

Brief Summary

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Breast cancer is a chronic disease that has seen a boom in research into its treatments, improvements and effects in recent decades. These advances have also highlighted the need to use physical exercise as a countermeasure to reduce the cardiotoxicity of pharmacological treatments. Patients need a correct daily individualisation of the exercise dose necessary to produce the physiological, physical and psychological benefits. To this end, the present study will use, in a novel way in this population, heart rate variability (HRV) as a measure of training prescription. The primary objective of this randomised clinical trial is to analyse the effects of a physical exercise programme planned according to daily HRV in breast cancer patients after chemotherapy treatment. For this purpose, a 16-week intervention will be carried out with 90 breast cancer patients distributed in 3 groups (control group, conventional preprogrammed physical exercise training group and physical exercise group with HRV daily programming). Cardiorespiratory capacity, strength, flexibility, agility, balance, body composition, quality of life, fatigue, functionality, self-esteem, anxiety and depression of patients before and after the intervention will be evaluated in order to compare the effects of exercise and its programming.

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Detailed Description

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The intervention of 16 weeks will include exercise programmes of 48 sessions conducted three times per week for two of the three study groups. These groups will be: a group participating in a conventional training programme, based on a preplanned intensity progression; and, a group of participants involved in an exercise programme which will vary the exercise intensity regarding patients' daily Heart Rate Variability. Each session will include a warm-up, the main part of cardiovascular and strength training and a cool-down including stretching exercises.

All the participants will be evaluated before and after the intervention measuring clinical, physical and psychosocial assessments. The clinical variables will be evaluated in patients' reference hospital and will involve medical history registers, cardiotoxicity variables, blood analysis and inflammatory factors measures. Physical and psychosocial variables measurement will be carried out in a sports centre and will include the assessment of: body composition, heart rate variability, cardiorespiratory capacity, upper and lower extremities' strength and flexibility, agility and balance, quality of life, fatigue, functionality, life satisfaction, self-esteem, anxiety and depression, shoulder mobility perception, kinesiophobia, physical activity level and exercise motivation.

Conditions

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Breast Cancer Cardiotoxicity Autonomic Imbalance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group (CG)

Participants will continue with their daily life and usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Traditional periodization exercise group (TEG)

Participants will participate in a physical exercise program with a preplanned intensity progression.

Group Type EXPERIMENTAL

Physical exercise program

Intervention Type OTHER

The physical exercise programme will last 16 weeks where participants will do three weekly sessions of 60 minutes, approximately. In these training sessions, cardiovascular and strength components will be worked out, planned from moderate to high intensity in the TEG and unique high intensity in the HRVG. The training programme will be divided into three mesocycles from neuromuscular adaptation to reach, in last period, the highest loads and cardiovascular levels. Each session will include a warm-up, a main part and a cool-down with stretching and mobility exercises.

The difference between the interventions of the HRVG and TEG will be in the planning of the intensity of the cardiovascular exercises and the weight to be lifted in the strength exercises. The first session of both programmes will have the same intensity but depending on how the heart rate variability of the HRVG patients reacts to, the weight and the intensity will be individualised each day.

Heart Rate Variability exercise group (HRVG)

Participants will participate in a physical exercise program guide by participants' daily heart rate variability to plan the intensity progression.

Group Type EXPERIMENTAL

Physical exercise program

Intervention Type OTHER

The physical exercise programme will last 16 weeks where participants will do three weekly sessions of 60 minutes, approximately. In these training sessions, cardiovascular and strength components will be worked out, planned from moderate to high intensity in the TEG and unique high intensity in the HRVG. The training programme will be divided into three mesocycles from neuromuscular adaptation to reach, in last period, the highest loads and cardiovascular levels. Each session will include a warm-up, a main part and a cool-down with stretching and mobility exercises.

The difference between the interventions of the HRVG and TEG will be in the planning of the intensity of the cardiovascular exercises and the weight to be lifted in the strength exercises. The first session of both programmes will have the same intensity but depending on how the heart rate variability of the HRVG patients reacts to, the weight and the intensity will be individualised each day.

Interventions

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Physical exercise program

The physical exercise programme will last 16 weeks where participants will do three weekly sessions of 60 minutes, approximately. In these training sessions, cardiovascular and strength components will be worked out, planned from moderate to high intensity in the TEG and unique high intensity in the HRVG. The training programme will be divided into three mesocycles from neuromuscular adaptation to reach, in last period, the highest loads and cardiovascular levels. Each session will include a warm-up, a main part and a cool-down with stretching and mobility exercises.

The difference between the interventions of the HRVG and TEG will be in the planning of the intensity of the cardiovascular exercises and the weight to be lifted in the strength exercises. The first session of both programmes will have the same intensity but depending on how the heart rate variability of the HRVG patients reacts to, the weight and the intensity will be individualised each day.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being between 18 and 65 years
* Being a breast cancer patient with luminal or triple-negative
* Having completed the radiotherapy treatment, after chemotherapy, approximately one month ago.
* Be able to perform the proposed tests safely